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NCT04903470 · ClinicalTrials.gov registry record · NA
Defecation Patterns in Constipated Patients
A NA study of Constipation by Outlet Obstruction, sponsored by The California Medical Innovations Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 2
- Study locations
NCT04903470 is a NA study of Constipation by Outlet Obstruction that is actively recruiting participants, run by The California Medical Innovations Institute. The registered enrollment target is 130 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT04903470, a NA study of Constipation by Outlet Obstruction, is actively recruiting participants, sponsored by The California Medical Innovations Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 2
- Study locations
Study Summary
Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deforma
Conditions Studied
Interventions
- DRUG Bisacodyl
- DRUG Atropin
Study Locations (2)
California
- California Medical Innovations Institute - San Diego
Georgia
- Augusta University Medical Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04903470
The ClinicalTrials.gov registry entry for NCT04903470 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The California Medical Innovations Institute, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Constipation by Outlet Obstruction appearing as the primary indexed condition, and to 2 interventions - of which Bisacodyl is the first listed.
NCT04903470 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04903470 about?
NCT04903470 is a clinical study titled "Defecation Patterns in Constipated Patients". Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide inc...
What is the current status of trial NCT04903470?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2022-12-19. Estimated completion is 2026-12-30.
What conditions does trial NCT04903470 study?
This clinical trial studies the following conditions: Constipation by Outlet Obstruction.
What interventions are being tested in trial NCT04903470?
The interventions under investigation include: Bisacodyl (DRUG), Atropin (DRUG).
Who is sponsoring clinical trial NCT04903470?
This trial is sponsored by The California Medical Innovations Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04903470 being conducted?
This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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